Catheter Including Composite Guide and Methods for use and manufacturing of the Same

ABSTRACT

A catheter assembly includes a catheter body having a catheter lumen. A manifold assembly is coupled with a proximal catheter portion. A manifold lumen extends through the manifold assembly, and the manifold lumen includes an assembly cavity extending around the proximal catheter portion. A fluid jet loop is coupled with a high pressure tube at a distal catheter portion. The catheter assembly further includes a composite guide having first and second guide portions. The first guide portion includes a proximal guide insert near the proximal catheter portion, the proximal guide insert is positioned within the assembly cavity, and includes a guide insert surface flush with a catheter body interior wall. The second guide portion includes a distal guide near the distal catheter portion including a tapered loop guide surface and an intermediate guide surface of the catheter lumen flushly engaged with a leading edge of the tapered loop guide surface.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a non-provisional of U.S. Application No. 61/286,849filed Dec. 16, 2009, the contents of which are incorporated herein byreference.

TECHNICAL FIELD

Catheters and guiding of instruments through catheters.

BACKGROUND

To guide a catheter to a desired treatment site introducers and guidewires are used. In the case of guide wires, the guide wire is positionedwithin the vessel near the treatment site and the catheter is fed overthe guide wire. The catheter follows the path of the guide wire throughthe vasculature until a portion of the catheter, such as the distal tip,reaches the treatment site. In some examples, the catheter includes adedicated guide wire lumen sized and shaped to slidably receive theguide wire. The guide wire lumen may be entirely isolated from the otherfeatures of the catheter, including instrument lumens, instruments andthe like. The provision of the guide wire lumen requires an allotment ofspace in the catheter to accommodate a guide wire. Alternatively, thecatheter can be made larger to accommodate both the guide wire lumen andthe desired instruments and instrument lumens. Larger catheters can havedifficulty navigating the tortuous vasculature of the body and in somecases are unable to reach a treatment site in smaller vessels becausethey are simply too large to fit within the vessels.

In other examples, the guide wire is fed through an instrument ordelivery lumen thereby consolidating the functions of a guide wire lumenand an instrument lumen into a single passage. In many examples,instruments, tubes and the like are positioned within instrument lumensthat provide a discontinuous surface related to the function orconstruction of the catheter. These discontinuous surfaces snag guidewires that are fed into the instrument lumens preventing furtheradvancement of the guide wires. This difficulty is further aggravatedwith guide wires having curved features designed to navigate bends inthe vasculature. The curved features easily catch on the discontinuoussurfaces of the instrument lumen and interrupt the smooth delivery ofthe instrument through the catheter. Stated another way, theinterruptions in the consolidated lumen easily snag and halt the desiredadvancement of a curved guide wire. Because of these difficulties, asolution is needed for smoother transport of guide wires and the likeinside of catheters.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of one example of a thrombectomy catheter

FIG. 2 is a cross-sectional view of one example of the manifold assemblyincluding an example guide insert of a composite guide.

FIG. 3A is a cross-sectional view of one example of a distal catheterportion including an example fluid jet loop having a tapered guidesurface of the composite guide.

FIG. 3B is a sectional perspective view of the distal catheter portionincluding the fluid jet loop shown in FIG. 3A.

FIG. 3C is a sectional perspective view of the distal catheter portionincluding the fluid jet loop shown in FIG. 3A with the tapered guidesurface.

FIG. 4A is a detailed perspective view of one example of a guide insert.

FIG. 4B is a detailed top perspective view of the guide insert shown inFIG. 4A.

FIG. 5A is a detailed bottom view of one example of a fluid jet loopwithin the catheter body including a tapered guide surface.

FIG. 5B is a detailed side view of the fluid jet loop shown in FIG. 5A.

FIG. 6A is a detailed bottom view of another example of a fluid jet loopincluding a tapered guide surface coupled with a support ring.

FIG. 6B is a detailed side view of the fluid jet loop and support ringshown in FIG. 6A.

FIG. 7 is a block diagram showing one example of a method for making athrombectomy catheter including a composite guide.

FIG. 8 is a block diagram showing one example of a method for using athrombectomy catheter having a composite guide.

DESCRIPTION OF THE EMBODIMENTS

In the following detailed description, reference is made to theaccompanying drawings which form a part hereof, and show, by way ofillustration, specific embodiments in which the device of the presentdisclosure may be practiced. These embodiments are described insufficient detail to enable those skilled in the art to practice theteachings of the present disclosure, and it is to be understood thatother embodiments may be utilized and that structural changes may bemade without departing from the scope of the present disclosure.Therefore, the following detailed description is not to be taken in alimiting sense, and the scope of the present disclosure is defined bythe appended claims and their equivalents.

One example of a thrombectomy catheter 100 is shown in FIG. 1. Thethrombectomy catheter 100 includes a catheter body 104 and a manifoldassembly 102. The manifold assembly 102 includes a manifold proximalportion 106 and a manifold distal portion 108. A exhaust tube 120extends into the manifold assembly 102. As shown in FIG. 1, in oneexample, the exhaust tube receives an injection port 118 and thereafterextends into the manifold assembly 102 where it meets with a manifoldlumen shown in later figures. An introducer 116 is received in themanifold proximal portion 106. Referring again to FIG. 1, the introducer116 is received within an introducer lumen 117 in the manifold proximalportion 106. The introducer lumen 117 and the lumen within theintroducer 116 are in communication with the manifold lumen and acatheter lumen extending through the catheter body 104.

The catheter body 104 extends away from the manifold assembly 102. Asshown in FIG. 1, a strain relief fitting 110 is coupled between thecatheter body 104 at the catheter proximal portion 112 and the manifoldassembly 102 at the manifold distal portion 108. The catheter body 104extends away from the manifold assembly 102 toward a catheter distalportion 114. In one example, the catheter body 104 includes a cathetersupport, such as a braided catheter support 115. Referring to FIG. 1,the braided catheter support 115 is shown in a partial cutaway view withcross hatching. Optionally, the braided catheter support 115 extendsthrough a portion of the catheter body 104. In yet another option, thebraided catheter support 115 extends throughout the catheter body 104.

The catheter distal portion 114 includes one or more outflow orifices122 and one or more inflow orifices 124. As described in further detailbelow the inflow and outflow orifices 124, 122 cooperate with fluid jetsto provide a cross stream effect wherein fluid is projected from thecatheter body 104 through the outflow orifice 122 and returns to thecatheter body 104 through the inflow orifice 124. The fluid entering andexiting the catheter body 104 thereby develops a circular or crossstream flow that is able to engage with thrombus material within avessel, break up the thrombus material and draw the thrombus particlesinto the catheter body 104. The catheter distal portion 114 furtherincludes a guide wire orifice 126. The guide wire orifice 126 is sizedand shaped to receive and pass through a guide wire extending within thecatheter 100, for instance, a guide wire extending through theintroducer 116, a manifold lumen within the manifold assembly 102, thecatheter body 104 and finally through the guide wire orifice 126. In oneoption, a guide wire is back loaded into the catheter 100. For example,the guide wire is back loaded through the introducer 116, into thecatheter body 104 and out of the guide wire orifice 126 and into thevasculature. In another option, the catheter 100 is fed over a guidewire fed first through the guide wire orifice 126 and through at least aportion of the catheter body 104 (e.g., an over the wire or rapidexchange catheter).

FIG. 2 shows the manifold assembly 102 in a cross sectional view. Amanifold lumen 200 extends through the manifold assembly 102 from themanifold proximal portion 106 to the manifold distal portion 108. Asshown in FIG. 2, the catheter lumen 202 is in communication with themanifold lumen 200. The catheter body 104 is coupled with the manifoldassembly 102 with the strain relief fitting 110 previously shown inFIG. 1. The strain relief fitting 110 is shown in FIG. 2 extendingaround the catheter body 104 and engaged with the manifold assembly 102.

As previously discussed, the exhaust tube 120 and the injection port 118are in communication with one another and also in communication with themanifold lumen 200. A high pressure tube 204 such as a stainless steelhypo tube extends through the exhaust tube 120 and into the manifoldlumen 200 where the high pressure tube 204 continues to extend throughthe catheter lumen 202 toward the catheter distal portion 114 shown inFIG. 1.

As shown herein the thrombectomy catheter 100 includes a composite guide128 having at least a first guide portion 214 (shown in FIG. 2) near themanifold assembly 102 and a second guide portion 311 (described belowand shown in FIGS. 3A, B) near the catheter distal portion 114. Thecomposite guide 128 directs guide wires, flow wires or other instrumentsthrough the lumens of manifold assembly 102 and catheter body 104 usedto perform a thrombectomy procedure. Snagging of an instrument, such asa guide wire, within the thrombectomy catheter 100 is thereforeminimized by the composite guide 128. It will be understood by those ofskill in the art that any diagnostic or therapeutic instrument that canbe delivered through a catheter could benefit from the composite guideof the present disclosure.

Referring to FIG. 2, the first guide portion 214 includes a guide insert208 that provides a smooth transition between the manifold assembly 102and the catheter body 104. In one example, the guide insert 208 isconstructed with, but not limited to, metals, plastics and the like. Theguide insert 208 is formed by one or more of molding, machining,casting, and the like. The first guide portion 214 including the guideinsert 208 is positioned within an assembly cavity 206 of the manifoldassembly 102. The assembly cavity 206 shown in FIG. 2 facilitatesconstruction of the catheter 100. For instance, the catheter componentsare fed through the exhaust tube 120 and into the assembly cavity 206before being fed into the catheter body 104 toward the catheter distalportion 114. Once the components of the catheter 100 are assembled theguide insert 208, in one example, is fed down the exterior of thecatheter body 104 and into engagement with the manifold assembly 102.The guide insert fills the assembly cavity 206. The guide insert surface210 is flush with a catheter body interior wall 212 of the catheter body104 and a manifold interior wall 201. The guide insert surface 210cooperates with the catheter body interior wall 212 and the manifoldinterior wall 201 to form the first guide portion 214.

Referring now to FIGS. 3A-C, the catheter distal portion 114 is shown.As previously described, the thrombectomy catheter 100 provides a crossstream flow to break up thrombus and then draw it into the catheter 100for removal of the thrombus from the vessel. The fluid jet loop 300shown in FIGS. 3A-C is a circular or semi-circular fixture within thecatheter body 104. The fluid jet loop 300 produces fluid jets 303 (SeeFIGS. 3A and 3B) to create the cross stream flow 312 and thereby removeand exhaust thrombus from the vessel.

The fluid jet loop 300 extends around the catheter body interior wall212. In one example, the fluid jet loop 300 is engaged with a catheterbody interior wall 212 along a loop perimeter surface 306. As shown inFIGS. 3A-C, the fluid jet loop 300 includes fluid jet orifices 302directed in a proximal direction toward the catheter proximal portion112 shown in FIG. 1. Stated another way, the fluid jet orifices 302 aredirected within the catheter lumen 202 along the axis of the catheterbody 104 toward the catheter proximal portion 112. The fluid jetorifices generate the fluid jets 303 and correspondingly generate thecross stream flow 312. In one example, the fluid jet orifices 302 areconfigured to provide a jet flow velocity of between around 1 and 500meters per second.

In the example shown in FIGS. 3A-C, the fluid jet loop 300 includes atapered guide surface 304 (e.g., a tapered loop guide surface) formingpart of the second guide portion 311 of the composite guide 128. Theloop leading edge 308 of the tapered guide surface 304 is flushlyengaged with an intermediate guide surface 310, for instance, thecatheter body interior wall 212 shown in FIG. 3. Referring to FIGS. 3Band 3C, the tapered guide surface 304 tapers away from the intermediateguide surface 310 distally toward a fluid jet loop lumen 320 extendingthrough the fluid jet loop 300. As shown in FIG. 3C as well as otherFigures discussed herein, the tapered guide surface 304 provides afunnel-like effect that guides instruments, such as guide wires, towardthe fluid jet loop lumen 320 and away from the catheter body interiorwall 212. Stated another way, the tapered guide surface 304 provides abeveled transition from the catheter body interior wall 212 to the fluidjet loop lumen 320. In another alternative embodiment, not shown,tapered guide surface 304 can appear as merely a beveled ring at thedistal end of the catheter without being connected to high pressure tube204 or any other instrument. Those of skill in the art can appreciateadhesion techniques for a beveled metal ring being attached to theinside wall of a catheter such as those described herein. Stated anotherway, marker band 318 such as a radio-opaque marker band, or support ring316, could all be fashioned with a beveled edge within the scope of thepresent disclosure to allow for smoother delivery of guide wires orother instruments.

As will be described in further detail below, the tapered guide surface304 and the intermediate guide surface 310 form the second guide portion311 of the composite guide 128. As described above, the composite guide128 includes the second guide portion 311 and the first guide portion214 shown in FIG. 2. The tapered guide surface 304 of the fluid jet loop300 is formed with one or more techniques including, but not limited to,forming, coining, molding, casting, machining and the like. The fluidjet loop 300 is constructed with, but not limited to, metals such asstainless steel, plastics and the like.

The fluid jet loop 300, in one example, is coupled with a support ring316 (also shown in FIGS. 3A-C). As shown in FIGS. 3A and 3B, supportring 316 extends around the catheter body interior wall 212 and isengaged with an annular shoulder 324 formed in the catheter bodyinterior wall. The support ring 316 includes an annular groove 326 sizedand shaped to receive the annular shoulder 324 and thereby hold thesupport ring and the fluid jet loop 300 coupled thereto in place withinthe catheter body 104. As further shown in FIGS. 3A and 3B, the supportring 316 includes a support ring lumen 322 in communication with thefluid jet loop lumen 320. In operation, the fluid jet loop lumen 320 isaligned with the ring lumen 322 to allow a guide wire shown with guidewire tip 328 (in FIG. 3A) to pass through the fluid jet loop 300 and thesupport ring 316 on the way to the guide wire orifice and the catheterdistal portion 114 shown in FIG. 1. Stated another way, the taperedguide surface 304 cooperates with the intermediate guide surface 310 tofunnel an guide wire or other instrument into the fluid jet loop lumenfor passage through tortuous features in the catheter. In still anotherexample, the catheter distal portion 114 further includes a marker band318 such as a radio-opaque marker band. As shown in FIGS. 3A, B, themarker band 318 is coupled around the exterior of the catheter body 104.For instance, the marker band 318 is positioned within the recess formedby the annular shoulder 324 for the support ring 316.

The fluid jet orifices 302, as previously described, are directed towardthe catheter proximal portion 112. The fluid jets 303 emanating from thefluid jet orifices 302 are thereby also directed in the proximaldirection. The fluid jets 303 create a pressurized flow of fluid fromthe catheter distal portion 114 toward the catheter proximal portion 112(e.g., fluid jets having a velocity of between around 1 to 500 metersper second according to the configuration of the fluid jet orifices 302and the pressure of the fluid). As shown in FIGS. 3A, B, the fluid jets303 create a cross stream flow 312. The cross stream flow 312 passesthrough the outflow orifice 122, travels outside of the catheter body104 and returns into the catheter body 104 by way of the inflow orifice124. In one example, the cross stream flow has a flow velocity at one ormore of the inflow and outflow orifices 124, 122 that is typicallywithin the range of the flow generated by the flow velocity from thefluid jet orifices of between around 1 to 500 meters per second,although the cross stream flow usually is lower than the maximumvelocity of the flow from the jet orifices. The cross stream flow 312thereby has a cyclical pattern that engages the pressurized fluid in theflow against the thrombus within a vessel and breaks up and removes thethrombus off of the vessel wall. The cross stream flow 312 moves thethrombus particles along with entrained fluid into the catheter body 104through the inflow orifice 124 where the exhaust flow from the fluidjets 303 carries the particles proximally toward the catheter proximalportion and the manifold assembly 102 shown in FIG. 1. The exhaustedthrombus particles are thereafter removed from the catheter 100 by wayof the exhaust tube 120 (also shown in FIG. 1).

Optionally, the high pressure tube 204 extends over the inflow andoutflow orifices 124, 122 and provides a virtual screen to preventinstruments, including guide wires, from wandering out of the catheterbody through the orifices 124, 122. Where the high pressure tube 204 ispositioned over the orifices 124, 122, the high pressure tube is part ofthe composite guide 128. The high pressure tube 204 cooperates with thefirst and second guide portions 214, 311 of the composite guide 128 toreliably guide an instrument such as a guide wire through thethrombectomy catheter 100 without snagging. Stated another way, the highpressure tube 204 positioned over the inflow and outflow orifices 124,122 further ensures an instrument such as a guide wire is smoothly fedproximally or distally through the thrombectomy catheter 100 whileminimizing snagging and wandering of the guide wire or other instrument.

Composite Guide

As discussed above, the guide insert 208 and the tapered guide surface304 of the fluid jet loop 300 mated with the intermediate guide surface310 form the first and second guide portions 214, 311, respectively, ofa composite guide 128. The first and second guide portions 214, 311cooperate to ensure an instrument, such as a guide wire, is reliably fedthrough the manifold assembly 102, the catheter body 104 and out of thecatheter distal portion 114 through the guide wire orifice 126. Thefirst and second guide portions 214 and 311 ensure an instrument such asa guide wire is fed through the thrombectomy catheter 100 consistentlywithout engagement and snagging against features within the manifoldassembly 102 and the catheter body 104.

Referring to FIG. 2, the first guide portion 214 adjacent to themanifold assembly 102 ensures that a guide wire fed into the manifoldassembly 102 reliably moves through the manifold assembly 102, past theassembly cavity 206 and into the catheter lumen 202 of the catheter body104 on its way to the catheter distal portion 114. The composite guide128 including the first guide portion 214 and the second guide portion311 thereby ensures reliable and consistent feeding of a guide wire (orother instrument) through the thrombectomy catheter 100 withoutundesirable snagging of the guide wire within the catheter 100.Optionally, the catheter body 104 and the catheter lumen 202 extendingthrough the body foam a portion of the composite guide 128. Forinstance, the surfaces of the catheter body 104 defining the catheterlumen 202 provide a smooth near-featureless surface that reliably guidesan instrument such as a guide wire toward the catheter distal portion114 (if back loaded) or the catheter proximal portion 112 (if frontloaded through the catheter distal portion). In still another example,the catheter lumen 202 is tapered between the catheter proximal portion112 and the catheter distal portion 114 to further assist in guiding aninstrument such as a guide wire toward the second guide portion 311including the tapered guide surface 304 of the fluid jet loop 300.

Referring now to FIGS. 4A and 4B, one example of the guide insert 208 isshown. The guide insert 208 includes a guide insert lumen 400 extendingthrough a guide insert barrel 402. The guide insert 208 further includesin the example shown a guide insert tail 404 extending away from theguide insert barrel 402. As shown in FIG. 2, the guide insert tail 404extends within the manifold assembly 102 toward the manifold proximalportion 106 and the guide insert barrel 402 is adjacent to the manifolddistal portion 108. The guide insert tail 404 shown in FIGS. 4A and 4Bincludes a guide insert slot 406 extending through the guide insert 208between a guide insert groove 408 and a guide insert exterior surface409. The high pressure tube 204 shown in FIG. 2 extends through theguide insert slot 406 and into the guide insert lumen 400. The highpressure tube 204 extends from the guide insert lumen into the catheterlumen 202. The guide insert slot 406 thereby provides an opening withinthe guide insert 208 to feed the high pressure tube 204 toward thecatheter distal portion 114.

Referring to FIGS. 2, 4A and 4B, as previously discussed, the guideinsert 208 including the guide insert surface 210 cooperates with thecatheter body interior wall 212 and the manifold interior wall 201 toform a first guide portion 214 of the composite guide 128. The guideinsert surface 210 provides a smooth transition to the catheter bodyinterior wall 212 thereby allowing reliable and consistent passage ofinstruments such as a guide wire through the manifold assembly 102 intothe guide insert 208 and through the catheter body 104 without snaggingthe guide wire or other instrument within the manifold assembly 102(e.g., within the assembly cavity 206).

As shown in FIGS. 4A and 4B, the guide insert surface 210 shown in theexample guide insert 208 extends across the guide insert groove 408 andinto the guide insert lumen 400. Referring to FIG. 2, the catheter body104 extends into at least a portion of the guide insert 208 and thecatheter body interior wall 212 is flushly engaged with at least aportion of the guide insert surface 210. The guide insert 208 includingthe guide insert surface 210 provides the guiding function by fillingthe assembly cavity 206 (See FIG. 2) and creating a smooth transitionfrom the manifold assembly 102 to the catheter body 104. The guideinsert 208 is shaped and configured for filling of the assembly cavity206 to ensure reliable guiding of an instrument such as a guide wireinto a catheter lumen 202 from the manifold lumen 200. As shown in FIG.2, the guide insert barrel 402 is sized and shaped to fit into a firstportion of the assembly cavity 206 adjacent to the manifold distalportion 108. The guide insert tail 404 is correspondingly sized andshaped to fit within a portion of the assembly cavity 206 proximal tothe first portion of the assembly cavity. For example, the guide inserttail 404 is fit within a portion of the assembly cavity 206 between themanifold lumen 200 and the exhaust tube 120 shown in FIG. 2. Statedanother way, the guide insert 208 fills the assembly cavity 206 in sucha way that the manifold lumen 200 is able to seamlessly communicate withthe catheter lumen 202 without providing cavities or structure capableof engaging with an instrument such as a guide wire and snagging orcatching the guide wire within the manifold assembly or the catheterproximal portion 112 engaged with the manifold assembly. An instrumentsuch as a guide wire fed through the manifold lumen 200 and the catheterlumen 202 cannot wander from the lumens into cavities, including theassembly cavity 206, because of the guide insert 208. The guide insertthereby bridges across the catheter body interior wall 212 and themanifold interior wall 201 and smoothly passes an instrument such as aguide wire between the manifold assembly 102 and the catheter body 104.

FIGS. 5A and 5B show one example of a fluid jet loop 500 that forms partof the second guide portion 311 shown in FIGS. 3A, B. FIG. 5A shows atop view of the jet loop 500 within the catheter body 104. FIG. 5B showsa side view of the jet loop 500. The jet loop 500 is positionable withinthe catheter body 104 in an orientation that directs the fluid jetorifices 302 in the desired direction. The fluid jet loop 500 is shownin both FIGS. 5A and 5B with the high pressure tube 204 coupled to thefluid jet loop 500 with an elbow 502. The high pressure tube 204 is incommunication with the interior of the fluid jet loop 500 by way of afluid passage 504 extending around the fluid jet loop and providing highpressure fluid to each of the fluid jet orifice 302 (see FIG. 5B).

As previously discussed above, the fluid jet loop 300 includes a loopperimeter surface 306 sized and shaped for coupling with the catheterbody interior wall 212 shown in FIG. 2 (e.g., intermediate guide surface310 shown in FIGS. 3A, B). As shown in FIGS. 5A and 5B, in one example,the loop perimeter surface 306 is substantially planar and therebyengages along the intermediate guide surface 310. The fluid jet loop 500further includes the tapered guide surface 304 including the fluid jetorifices 302. That is to say, the fluid jet orifices 302 extend throughthe tapered guide surface 304. As shown in FIGS. 5A and 5B, the taperedguide surface 304 extends around the entirety of the fluid jet loop 500.In another example, the tapered guide surface 304 extends over a portionof the fluid jet loop 500, for instance, an arc measuring anywhere from0 to 360 degrees. The fluid jet loop 500 includes the fluid jet looplumen 320 extending through the jet loop. The fluid jet loop lumen 320is sized and shaped to pass an instrument such as a guide wire throughthe fluid jet loop 500 on a path to the guide wire orifice 126 shown inFIG. 1. Stated another way, the tapered guide surface 304 and theintermediate guide surface 310 cooperate to funnel a guide wire or otherinstrument through the fluid jet loop 300 (e.g., through fluid jet looplumen 320). Alternatively, the fluid jet loop 320 is sized and shaped toreceive a guide wire fed into the catheter body 104 through the guidewire orifice 126 (e.g., front loaded) where the guide wire is fedthrough the catheter proximal portion 102 shown in FIG. 1.

The tapered guide surface 304 is part of the second guide portion 311shown in FIGS. 3A-C. For example, the tapered guide surface 304 includesa loop leading edge 308 sized and shaped for substantially flushengagement with the intermediate guide surface 310. The tapered guidesurface 304 thereby provides a continuous guiding surface with theintermediate guide surface 310 to reliably and consistently direct aninstrument, such as a guide wire, fed through the catheter body 104through the fluid jet loop lumen 320 toward the guide wire orifice 126.The flush engagement between the leading edge 308 of the tapered guidesurface 304 and the intermediate guide surface 310 ensures that a guidewire (shown by the guide wire tip 328 in FIG. 3A) is fed through thefluid jet lumen 320 and the support ring lumen 322. Stated another way,if the guide wire tip 328 is fed along the interior wall 212 toward thecatheter distal portion 114 the guide wire tip engages with theintermediate guide surface 310 and rides from the intermediate guidesurface 310 over the tapered guide surface 304 (including the fluid jetorifices 302) because of the flush engagement between the loop leadingedge 308 and the intermediate guide surface 310. The smooth transitionbetween tapered guide surface 304 (appearing as a funnel-like surface inFIG. 3C) and intermediate guide surface 310 serves to funnel instrumentssuch as guide wires through convoluted features within the catheter(e.g., the fluid jet loop and the support ring 316) and forms the secondguide portion. The guide wire tip 328 is then fed into the fluid jetloop lumen 320 and the support ring 322 where it then moves toward theguide wire orifice 126 and extends out of the catheter 100 into thevessel as desired.

In the example shown at FIGS. 5A and 5B, the fluid jet loop 500 furtherincludes a distal loop surface 506. The distal loop surface 506 issubstantially orthogonal to the catheter body interior wall 212 shown inFIG. 2. The orthogonal distal loop surface 506 allows for easy couplingwith a structure such as the support ring 316 shown in FIGS. 3A, B andfurther described in FIGS. 6A and 6B. In yet another example, the distalloop surface 506 includes a tapered surface similar to the tapered guidesurface 304. In such an example the distal loop surface 506 includes aleading edge substantially flush with the catheter body interior wall212 (e.g., the intermediate guide surface 310). A distal loop surface506 would then taper toward the fluid jet loop lumen 320 and the distalloop surface 506 would thereby have a taper oriented at an angle opposedto the angle of the tapered guide surface 304. Stated another way, thefluid jet loop lumen 500 with the tapered distal loop surface 506includes a tapered guide surface 304 tapering from the proximal portionof the catheter body 104 toward the catheter distal portion 114 and adistal loop surface 506 tapering from the catheter distal portion 114toward the catheter proximal portion 112. Including tapered surfaces onthe tapered guide surface 304 and the distal loop surface 506 allows forback loading (insertion of a guide wire or other instrument through themanifold assembly 102 toward the catheter distal portion 114) and frontloading of instruments such as a guide wire or flow wire and the like(through the guide wire orifice 126 toward the manifold assembly 102)thereby providing additional flexibility for use of the catheter 100(FIG. 1). The ability to front load and back load an instrument in thecatheter 100 provides enhanced utility for an operator and eliminatesthe need to exchange catheters during a procedure.

FIGS. 6A and 6B show the fluid jet loop 500 coupled with the supportring 316. In one example, the fluid jet loop 500 is coupled with thesupport ring 316 by way of a weld. The fluid jet loop 500 is optionallycoupled with support ring 316 with one or more of a variety of featuresincluding but not limited to mechanical interference fittings,mechanical couplings, adhesives, molding and the like. The fluid jetloop 500 shown in FIGS. 6A and 6B includes at least some of the featuresshown in FIG. 3, FIGS. 5A and 5B. For instance, the fluid jet loop 500includes a tapered guide surface 304 including the fluid jet orifices302 configured to direct fluid jets toward a catheter proximal portion112. The fluid jet loop 500 further includes a loop leading edge 308sized and shaped for flush coupling with the intermediate guide surface310 (e.g., the catheter body interior wall 212).

As previously described, the support ring 316 includes a support ringlumen 322 extending through the support ring. As shown in FIG. 6B, thesupport ring lumen 322 is circumscribed by a distal support ring taperedsurface 600 and a support ring inner wall 602. The support ring 322includes an annular groove 326 sized and shaped to allow the supportring 322 to couple with the annular shoulder 324 of the catheter body104 (FIGS. 3A, B). As shown in FIGS. 6A and 6B the annular groove 326 ispositioned between the fluid jet loop 500 having the tapered guidesurface 304 and the distal support ring tapered surface 600. The supportring inner wall 602 extends over the annular groove 326.

The distal support ring tapered surface 600 allows for front loading ofan instrument, such as a guide wire, through the guide wire orifice 126shown in FIG. 1. A front loaded instrument such as a guide wire isinserted into the catheter body near the catheter distal portion 114(e.g., through the guide wire orifice 126) and fed toward the manifoldassembly 102. As shown in FIG. 6B, the support ring inner wall 602 issubstantially flush with a loop trailing edge 604. Where the fluid jetloop 500 flushly transitions from the loop trailing edge 604 to thesupport ring inner wall 602 a continuous guide surface is providedbetween the fluid jet loop 500 and the support ring 322 thereby allowingreliable and consistent delivery of instruments through the fluid jetloop 500 and support ring 322. Snagging of instruments (e.g., guidewires having curved tips) within the support ring 322 and fluid jet loop500 is thereby avoided because of the flush engagement between thesupport ring inner wall 602 and the loop trailing edge 604. Statedanother way, the distal support ring tapered surface 600 and the taperedguide surface 304 funnel instruments such as guide wires and thelike—whether back loaded or front loaded—through the catheter andsubstantially prevent snagging of the instruments on features within thecatheter. Provision of the distal support ring tapered surface 600together with the tapered guide surface 304 of the fluid jet loop 500thereby facilitates front loading and back loading of an instrument suchas a guide wire through the catheter body 104.

Referring now to FIG. 7, one example of a method 700 for making athrombectomy catheter is shown. Reference is made to componentspreviously described in FIGS. 1 through 6B. While reference is made toone or more similar components it is implicit that other similarcomponents and their equivalents are also included in the description ofthe method 700. The method 700 includes at 702 coupling a catheter body,such as catheter body 104, with a manifold assembly 102 (see FIG. 1).The catheter body 104 extends from a proximal catheter portion 112 to adistal catheter portion 114. The catheter body 104 further includes acatheter lumen 202 (See FIG. 2). The manifold assembly 102 includes amanifold lumen 200 (Also shown in FIG. 2). The catheter lumen 202 andmanifold lumen 200 are in communication. The manifold assembly 120further includes an assembly cavity, such as cavity 206 shown in FIG. 2.As shown in FIG. 2, the assembly cavity 206 extends around the catheterproximal portion 112. The assembly cavity 206 assists in assembly of thethrombectomy catheter 100. For instance, the high pressure tube 204(FIG. 2) and the fluid jet loop 300 (FIGS. 3A, B) are fed through theexhaust tube coupled with the manifold assembly 102 and into thecatheter body 104 for assembly.

At 704, a fluid jet loop, such as fluid jet loop 300, is coupled along acatheter body interior wall 212. The catheter body interior wall definesthe catheter lumen 202. The fluid jet loop 300 is coupled with a highpressure tube 204 extending from the manifold assembly 102. The fluidjet loop 300 includes a tapered guide surface 304 having fluid jetorifices 302. As shown in FIGS. 3A-C, the fluid jet orifices aredirected toward the proximal catheter portion 112 of the catheter body104.

The method 700 further includes at 706, forming two or more guideportions such as a first guide portion 214 and a second guide portion311 of a composite guide 128. The first guide portion 214 is locatednear the manifold assembly 102 and the second guide portion 311 includesthe tapered guide surface 304 near the distal catheter portion 114. Aspreviously described, the tapered guide surface 304 is part of the fluidjet loop 300 shown in FIGS. 3A-C.

At 708, forming the first guide portion 214 includes filling theassembly cavity 206 with a guide insert 208. The guide insert 208 fillsthe assembly cavity 206 and includes a guide insert surface 210 flushwith the catheter body interior wall. Referring to FIG. 2, the guideinsert surface 210 is flush and adjacent to the catheter body interiorwall 212 and thereby provides a smooth and consistent transition fromthe manifold assembly 102 to the guide insert 208, and from the guideinsert 208 to the catheter body 104.

At 710, the second guide portion 311 of the composite guide 128 isformed including flushly engaging a leading edge 308 of the taperedguide surface 304 of the fluid jet loop 300 to the catheter bodyinterior wall 212. In another example, the leading edge 308 of thetapered guide surface 304 is flushly engaged with an intermediate guidesurface 310. Optionally, the intermediate guide surface 310 includes thecatheter body interior wall 212. In yet another option, the intermediateguide surface 310 includes a supplemental feature of the catheter body104, for instance, a surface extending through and over a portion of thecatheter body 104.

Several options for the method 700 of making the thrombectomy catheter100 follow. In one example, filling the assembly cavity 206 with theguide insert 208 includes positioning a guide insert barrel 402 aroundthe proximal catheter portion 112. In another example, filling theassembly cavity 206 with the guide insert 208 includes positioning aguide insert tail 404 (see FIG. 4) over the interface between theexhaust tube 120 and the manifold lumen 200. As previously described,the guide insert tail 404 includes a guide insert slot 406 sized andshaped to allow the high pressure tube 204 to extend through the exhausttube 120 into the manifold lumen 200 and the catheter lumen 202.Further, the guide insert slot 406 of the guide insert tail 404 allowsfor communication between the catheter lumen 202, the manifold lumen 200and the injection port 118 extending away from the manifold assembly102. Exhaust from operation of the thrombectomy catheter moved throughthe guide insert slot 406 from the catheter lumen 202 and manifold lumen200 into the exhaust tube 120. The guide insert slot 406 is thereby ableto pass fluids including fluids having entrained thrombus to an exhausttube and further allows the high pressure tube to extend from theexhaust tube 120 into the catheter lumen 202 while at the same timereliably guiding an instrument such as a guide wire into the catheterlumen 202 from the manifold lumen 200. Further, the guide insert 208substantially prevents wandering of an instrument, such as a guide wire,out of the manifold lumen 200 and into cavities (e.g., the assemblycavity 206) within the manifold 102. In yet another example, the method700 further includes feeding the fluid jet loop 300 and the highpressure tube 204 through the assembly cavity 206 and the exhaust tube120 in the manifold assembly 102 prior to filling the assembly cavity206 with the guide insert 208. Stated another way, the assembly cavity206 provides additional space in the manifold 102 for facilitatingpositioning of the high pressure tube 204 and the fluid jet loop 300within the catheter body 104. The additional space allows the highpressure tube 204 and fluid jet loop 300 to easily navigate through theexhaust tube 120 and bend within the manifold assembly 102 to enter thecatheter lumen 202. After positioning of the fluid jet loop 300 and highpressure tube 204 the guide insert 208 is positioned within the assemblycavity 206 to fill the assembly cavity and provide the first guideportion 214 between the manifold lumen 200 and the catheter lumen 202.

FIG. 8 shows one example of a method 800 for using a catheter such asthe thrombectomy catheter 100 shown in FIG. 1. Method 800 refers toelements shown in FIGS. 1 through 6B. The references are exemplary andimplicitly include any alternative elements described and theirequivalents. At 802, an instrument, such as a guide wire, is fed intothe catheter 100. The guide wire tip 328 is shown, for example, in FIG.3A. The catheter includes a manifold assembly 102 coupled with acatheter body 104 at a proximal catheter portion 112. A catheter lumen202 extends through the catheter body 104 from the proximal catheterportion 112 to a distal catheter portion 114. An assembly cavity 206extends around the proximal catheter portion 112 within the manifoldassembly 102.

At 804, the instrument (e.g., a guide wire) is fed through at least thecatheter lumen 202 and a fluid jet loop 300 near a catheter distalportion 114. The instrument is fed into and through the catheter lumen202 by way of a composite guide surface including, for example, a firstguide portion 214 and a second guide portion 311. Feeding the instrumentincludes guiding the instrument into a catheter lumen through a guideinsert 208 and guiding the instrument over an intermediate guide surfaceflushly engaged with a tapered guide surface 304 of the fluid jet loop300.

At 806, the method 800 includes guiding the instrument into the catheterlumen 202 through the guide insert 208 filling the assembly cavity 206.The instrument is guided along a guide insert surface 210 flush with thecatheter body interior wall 212. As previously described, the flushtransition made by the guide insert surface 210 to the catheter lumen202 from the manifold lumen 200 substantially prevents wandering of theinstrument outside of the manifold lumen and the catheter lumen, forinstance, into the assembly cavity 206. The instrument is therebyreliably fed out of the manifold assembly 102 and into the catheterlumen 202 without lodging within spaces within the assembly cavity 206otherwise present for assembly purposes of the thrombectomy catheter100.

The method 800 further includes at 808, guiding the instrument, forinstance the guide wire shown by the guide wire tip 328 in FIG. 3A,along a distal guide such as the second guide portion 311 near thedistal catheter portion 114. The distal guide includes an intermediateguide surface 310 and a tapered guide surface 304 of the fluid jet loop300. The tapered guide surface includes fluid jet orifices 302 directedtoward the proximal catheter portion 112, as described above. As shownin FIG. 3A, the instrument 328 is guided along the intermediate guidesurface 310 through first, second, and third guide wire positions toillustrate the guide function of the second guide portion 311. At 330, afirst exemplary guide wire position, guide wire tip 328 is positionedproximally relative to the fluid jet loop 300 and is moved distallyalong the intermediate guide surface 310. At 332, in a second exemplaryguide wire position, guide wire tip 328 is moved past the outfloworifice 122 and is adjacent to the fluid jet loop 300. In a thirdexemplary guide wire position 334, guide wire tip 328 is guided throughthe fluid jet loop lumen 320 by the second guide portion 311. Theintermediate guide surface 310 is flushly engaged with a loop leadingedge 308. Guide wire tip 328 rides along the continuous surface createdby the intermediate guide surface 310 and the tapered guide surface 304to funnel guide wire tip 328 through the fluid jet loop lumen 320 of thefluid jet loop 300. Snagging of the guide wire, including a curved guidewire having a non-linear bent or hooked distal shape, is reliablyavoided because of the continuous guide surface of the second guideportion 311 of the composite guide 128.

Several options for the method 800 follow. In one example, feeding theinstrument through at least the catheter lumen 202 and the fluid jetlumen 300 includes the front loading of the instrument through a distalguide wire orifice such as guide wire orifice 126 shown in FIG. 1.Feeding the instrument through the catheter lumen 202 and the fluid jetloop 300 further includes back loading of the instrument through themanifold assembly 102. Stated another way, the instrument is fed throughthe introducer 116 positioned at the proximal portion of the manifoldassembly 102. From there the instrument is fed into the manifold lumen200 of the manifold assembly 202. In yet another option, where theinstrument is front loaded through the guide wire orifice 126 the guidewire tip, such as guide wire tip 328 is fed over a distal support ringtapered surface 600 shown in FIGS. 6A and 6B. The distal support ringtapered surface 600 acts in a similar manner to the tapered guidesurface 304 of the fluid jet loop 300 and funnels the guide wire tipthrough the support ring. The guide wire tip 328 is thereafter fed overthe support ring inner wall 602, and the support ring inner wall 602 issubstantially flush with the fluid jet loop 300 to guide the frontloaded instrument into the catheter lumen 202 for passage through thecatheter lumen to the manifold assembly 102. The ability to back loadand front load instruments increases the utility of the thrombectomycatheter 100 because the user does not need to exchange catheters duringa procedure.

The catheter and methods described above and shown in the figuresprovide a catheter assembly capable of using a single lumen to providethrombectomy therapy to a desired treatment site while also able tosmoothly navigate a guide wire or other instrument through the samelumen containing the thrombectomy apparatus. By including a compositeguide in the distal catheter portion and at the interface between themanifold assembly and the catheter body instruments including guidewires, are fed—without snagging on obstructions—through the manifoldassembly and the catheter body and out of an orifice in the distalcatheter portion. Guide wires, including guide wires having a variety ofshapes and bends, that are otherwise prone to snagging within a catheterbody are readily fed through the catheter body including the compositeguide. A composite guide including the first and second guide portionsis thereby able to facilitate consistent and reliable navigation of aguide wire through the catheter body.

An assembly cavity is provided within the manifold assembly tofacilitate assembly of the catheter. For instance, the high pressuretube and the fluid jet loop are fed through the assembly cavity toposition the high pressure tube and the fluid jet loop within thecatheter body. The guide insert is positioned within the manifoldassembly and fills the assembly cavity after the high pressure tube andthe fluid jet loop are positioned. The catheter body is fed into theguide insert and creates a substantially flush engagement and transitionbetween the catheter lumen and the manifold lumen. The guide insertforms a first guide portion of the composite guide. Instruments arereliably fed from the manifold into the catheter body without wanderinginto spaces including the assembly cavity. Stated another way, the guideinsert fills the assembly cavity and substantially eliminates anycavities for the guide wire to snag within as it is fed through themanifold assembly toward the catheter body distal portion. In a similarmanner the first guide portion guides an instrument front loaded (incontrast to back loading) through the catheter body into the manifoldassembly. The capability to front load and back load an instrumentminimizes the need to exchange a catheter able to perform front loadingor back loading for another catheter capable of performing the otherform of loading (i.e., back or front loading).

The second guide portion of the composite guide directs an instrument,such as a guide wire, through the catheter body and toward the distalcatheter portion. The intermediate guide surface (e.g., the catheterbody interior wall) flushly engages with the leading edge of the taperedguide surface of the fluid jet loop. As the guide wire is fed throughthe catheter lumen the guide wire slides along the intermediate guidesurface and slides over the continuous surface created by the taperedguide surface mated to the intermediate guide surface. The guide wiretip engages against the tapered guide surface of the fluid jet loop andrides over the tapered guide surface into the fluid jet loop lumen andtoward the guide wire orifice of the catheter. The intermediate guidesurface and the tapered guide surface of the fluid jet loop therebycooperate to form the second guide portion and funnel the instrumentthrough the fluid jet loop. In another example, where the fluid jet loopis coupled with a support ring the support ring includes a taperedsurface at its distal end that tapers toward a support ring innersurface that is substantially flush with a trailing edge of the fluidjet loop tapered guide surface. Front loading of the guide wire, forinstance, through the guide wire orifice is performed in a similarmanner to the back loading method previously described. For instance,the guide wire is fed over the support ring tapered guide surface intothe support ring and through the fluid jet loop lumen toward themanifold assembly. The second guide portion of the composite guide(e.g., the guide insert) provides a continuous smooth transition fromthe catheter body into the manifold assembly to feed the guide wire intothe manifold assembly.

The composite guide including the first and second guide portions isthereby able to guide an instrument through the catheter body containingelements and features necessary for thrombectomy action including, forexample, a high pressure tube, a fluid jet loop, inflow and outfloworifices, a support ring and the like. By providing the composite guidea guide wire is able to smoothly pass through the catheter lumenconsistently and reliably without snagging on features within thecatheter lumen. Further, the catheter is able to perform a thrombectomyprocedure and guide the instrument through the same lumen used for theprocedure. Stated another way, the thrombectomy catheter and methodsdescribed herein provide a catheter with a single lumen and compositeguide that consolidates operation of a thrombectomy system with deliveryof an instrument to a desired treatment site.

Although the present disclosure has been described in reference topreferred embodiments, persons skilled in the art will recognize thatchanges may be made in form and detail without departing from the spiritand scope of the disclosure. It is to be understood that the abovedescription is intended to be illustrative, and not restrictive. Manyother embodiments will be apparent to those of skill in the art uponreading and understanding the above description. It should be noted thatembodiments discussed in different portions of the description orreferred to in different drawings can be combined to form additionalembodiments of the present application. The scope of the presentdisclosure should, therefore, be determined with reference to theappended claims, along with the full scope of equivalents to which suchclaims are entitled.

1. A catheter comprising: a catheter body with a catheter lumenextending from a proximal catheter portion to a distal catheter portion;a manifold assembly coupled with the proximal catheter portion, amanifold lumen extends through the manifold assembly from a proximalmanifold portion to a distal manifold portion, the manifold lumen is incommunication with the catheter lumen, and the manifold lumen includesan assembly cavity extending around the proximal catheter portion; afluid jet loop coupled with a high pressure tube at the distal catheterportion, the fluid jet loop extends around a fluid jet loop lumen, thefluid jet loop includes fluid jet orifices along a tapered loop guidesurface, and the tapered loop guide surface tapers from a fluid jet loopouter perimeter toward a fluid jet loop inner perimeter and the fluidjet loop lumen; a composite guide including: a proximal guide insertpositioned within the assembly cavity, the proximal guide insertincludes a guide insert surface substantially flush with a catheter bodyinterior wall, and the proximal guide insert is configured to guide aninstrument past the assembly cavity and into the catheter lumen, and adistal guide including the tapered loop guide surface and anintermediate guide surface of the catheter lumen flushly engaged with aleading edge of the tapered loop guide surface, wherein the distal guideis configured to guide the instrument over the intermediate guidesurface, the tapered loop guide surface and through the fluid jet loop.2. The catheter of claim 1, wherein the tapered guide surface tapersinwardly away from the intermediate guide surface toward the fluid jetloop lumen.
 3. The catheter of claim 1, wherein the fluid jet loopincludes a distal loop guide surface, and the distal loop guide surfacetapers inwardly from a distal edge flushly engaged with the intermediateguide surface toward a fluid jet loop lumen.
 4. The catheter of claim 1,wherein the intermediate guide surface includes the catheter bodyinterior wall.
 5. The catheter of claim 1 further comprising a supportring coupled with the fluid jet loop, and the support ring includes asupport ring lumen in communication with a fluid jet loop lumen.
 6. Thecatheter of claim 1, wherein the catheter body includes one or moreinflow and outflow orifices extending from the catheter lumen to acatheter exterior near the catheter distal portion, and the one or moreinflow orifices are positioned between the one or more outflow orificesand the fluid jet loop.
 7. The catheter of claim 6, wherein one or moreof the inflow and outflow orifices are configured to receive a fluidflow over the catheter exterior of around 1 to 500 meters per second,and the fluid flow at least extends from one or more of the outfloworifices to one or more of the inflow orifices.
 8. A method of making acatheter comprising: coupling a catheter body with a manifold assembly,the catheter body extends from a proximal catheter portion to a distalcatheter portion, the catheter body includes a catheter lumen, and themanifold assembly includes a manifold lumen in communication with thecatheter lumen, the manifold lumen extends from a proximal manifoldportion to a distal manifold portion, the manifold assembly includes anassembly cavity extending around the proximal catheter portion; couplinga fluid jet loop within the catheter lumen, the fluid jet loop iscoupled with a high pressure tube extending from the manifold assembly,and the fluid jet loop includes a tapered guide surface having fluid jetorifices; and forming a guide surface extending within one or more ofthe manifold lumen and the catheter lumen, forming the guide surfaceincludes: forming two or more guide portions including a first guideportion located near the manifold assembly, and a second guide portionincluding the tapered guide surface near the distal catheter portion,forming the first guide portion includes filling an assembly cavity witha guide insert, and the guide insert includes a guide insert surfaceflush with a catheter body interior wall, and forming the second guideportion includes flushly engaging a leading edge of the tapered guidesurface of the fluid jet loop to the catheter body interior wall.
 9. Themethod of making a catheter of claim 8, wherein filling the assemblycavity with the guide insert includes positioning a guide insert barrelextending around the proximal catheter portion.
 10. The method of makinga catheter of claim 8 further comprising feeding the fluid jet loop anda high pressure tube through the assembly cavity and a exhaust tube inthe manifold assembly before filling the assembly cavity with the guideinsert.
 11. The method of making a catheter of claim 8, wherein formingthe second guide portion includes coining the fluid jet loop to form thetapered guide surface.
 12. A method of using a catheter comprising:feeding an instrument into the catheter, the catheter includes amanifold assembly coupled with a catheter body at a proximal catheterportion, a catheter lumen extends through the catheter from the proximalcatheter portion to a distal catheter portion, and an assembly cavityextends around the proximal catheter portion; and feeding the instrumentthrough at least a catheter lumen and a fluid jet loop, and theinstrument is fed into and through the catheter lumen by way of acomposite guide surface, wherein feeding the instrument includes:guiding the instrument into the catheter lumen through a guide insertfilling the assembly cavity, and the instrument is guided along a guideinsert surface in the proximal guide insert flush with a catheter bodyinterior wall, and guiding the instrument along a distal guide near thedistal catheter portion, wherein the distal guide includes anintermediate guide surface and a tapered guide surface of the fluid jetloop, and the tapered guide surface includes fluid jet orifices, and theinstrument is guided along the tapered guide surface and theintermediate guide surface flushly engaged with a leading edge of thetapered guide surface.
 13. The method of using a catheter of claim 12,wherein feeding the instrument through at least the catheter lumen andthe fluid jet loop includes front loading of the instrument through adistal guide wire orifice in the catheter body and back loading of theinstrument through the manifold assembly.